Class 2 Device Recall CORDIS Peripheral Steerable Guidewire

• Date Initiated by Firm: July 21, 2006
• Date Posted: September 09, 2006
• Recall Status: Terminated on November 19, 2008
• Recall Number: Z-1494-06
• Recall Event ID: 35940
• 510(K)Number: K930091
• Product Classification: Peripheral Steerable Guidewire - Product Code DXQ
• Product: CORDIS SV-8 Steerable Guidewire, 180 cm. , 5 Steerable Guidewires, Cordis a Johnson Johnson Company, ENDOVASCULAR, Manufactured for: Cordis Corporation, Miami, FL 33102-5700. USA., Catalog # 503658
• Code Information: 70306850 70406741 70406797 70506746
• FEI Number: 1016427
• Recalling Firm/ Manufacturer: Cordis Corporation; 14201 NW 60th Ave; Miami Lakes FL 33014-2802
• Manufacturer Reason for Recall: Tip separation-Cordis SV-5 and SV-8 Steerable Guidewires may have a potential for guidewire fracture resulting in tip separation.
• FDA Determined Cause: Other
• Action: A recall of all lots manufactured by the OEM was initiated by letter dated July 21, 2006. All lots of the SV-5 guidewire and related design SV-8 guidewire were placed on Stop Shipment 6/30/06.
• Quantity in Commerce: 6,764
• Distribution: World wide Distribution-USA and Japan, Canada, Panama, Peru, Puerto Rico, Uruguay, Mexico and The Netherlands
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DXQ